Status:
UNKNOWN
Preoperative Lymph Node Staging With EBUS-TBNA in Clinical N0 Non Small-cell Lung Cancer
Lead Sponsor:
European Institute of Oncology
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The introduction of modern staging systems has increased the detection of small peripheral lung cancers at an early stage \[1\]. Stage I non-small-cell lung cancers (NSCLCs) are confined to the lung w...
Detailed Description
BACKGROUND AND RATIONALE The introduction of modern staging systems such as computed tomography (CT) and positron emission tomography/CT (PET/CT) with fluorodeoxyglucose (FDG) has increased the detect...
Eligibility Criteria
Inclusion
- Suspected or proven non-small cell lung cancer (NSCLC) clinical stage I and II (diameter \> 1 cm and less than 5 cm, no pleura invasion) clinical N0M0 (8th TNM)
- All patients have to be staged by total body CT scan and PET-FDG
- Negative preoperative staging at hilar and mediastinal level at CT and CT/PET (PET negative and lymph node short axis \< 1 cm at CT scan)
- Age between 18 and 75 years old
Exclusion
- NSCLC smaller or equal than 1 cm
- Unfit for bronchoscopy or surgical resection
- Evidence of locally advanced or metastatic disease
- Prior chemotherapy or radiotherapy for this malignancy
- Other malignancy within the past 5 years except for not melanoma skin cancer, superficial bladder cancer or carcinoma in situ of the cervix
- Previous surgical treatment for lung cancer
- Multiple lung tumors
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 20 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04828850
Start Date
April 1 2021
End Date
December 20 2022
Last Update
March 22 2022
Active Locations (1)
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1
European Institute of Oncology
Milan, Milano, Italy, 20141